Sr. Specialist - Engineering Compliance

Fujifilm•College Station, TX

8d•Onsite

About The Position

The Engineering Compliance Sr Specialist assists with the managing of Validation/Automation/Lab Engineering deviations, CAPAs, and change controls / action items, work orders, and assists in supporting other activities required for these groups. The work we do at FUJIFILM Biotechnologies Texas has never been more important—and we are looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions. If you’re ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we’re proud to cultivate a culture that will fuel your passion, energy, and drive—what we call Genki. Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it’s a dynamic location that blends convenience with innovation. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.”

Requirements

Excellent oral and written communication skills, interpersonal and organizational skills.
Excellent organizational, analytical, data review and report writing skills.
Practical understanding of equipment used in bioprocessing (downstream and/or upstream).
Proficient with Microsoft Office applications.
Good self-discipline and attention to detail.
Must have flexible work hours – must be willing to work outside of normally-scheduled hours as necessary; including opportunities for alternative shift-hours and weekends as required.
Ability to multitask and easily prioritize work.
Ability to work independently with little supervision.
Experience working in pharmaceutical industry.
Must have good planning skills and must be willing to interface with and support team members in many different roles and functions throughout the facility.
Bachelor’s Degree in an Engineering discipline or Life Science. Eight (8) years’ experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance role; OR
Master’s Degree in an Engineering discipline or Life Science. Six (6) years’ experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance role.

Nice To Haves

Experience authoring CAPAs and change controls, and investigating deviations for validation and/or automation.
Knowledge of validation in pharmaceutical or other regulated industry.
Experience with leading teams for problem solving.

Responsibilities

Manages the initiation of new deviations.
Leads deviation, CAPA, and change control/action item closure for Validation/Automation/Lab Engineering.
Timely creation of deviation(s) due to validation-based periodic review and requalification efforts.
Assists with leading Root Cause Analysis Investigations
Manages continuous improvement initiatives to reduce and/or eliminate deviation re-occurrence.
Schedules and facilitates post lessons learned.
Supports leading the completion of periodic reviews / revisions for quality documents.
Support the engineering organizations during internal and external audits.
Support the external and internal Audit Programs to be in an acceptable state of compliance.
Work with Quality and management to implement program improvements.
Responsible for audit preparations, assisting internal audits and client audits with site documentation collation.
Provides and maintains metrics around requalification and periodic reviews work orders, including deviation, CAPA and change control status.
Monitor work order volumes to determine when level-loading should be implemented.
Act as a Training Coordinator for Validation / Automation / Lab Engineering by verifying training status and updating department training curriculum as required.
Lead investigations for deviations and events.
Generate impact assessments for deviations and events.
Lead investigations including identification of root and/or contributing causes.
Ensures required Management and Quality approvals on final investigations while satisfying established due dates.
Facilitates corrective and preventive action agreement with stakeholders.
Support client due diligence and Quality audits as well as regulatory inspections.
Promptly notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
Support the routine maintenance and calibration of Validation equipment by the monitoring and scheduling of any preventive or corrective work required.
Ensure all equipment utilized on the floor for Validation execution is entered correctly into the Asset Management System.
Is the point of contact for client and regulatory inspection support with trends and metrics.
All other duties as assigned.